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    Process Validation Engineer - Durham, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Durham, United States

    3 weeks ago

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    Description
    Responsibilities:
    • Develop and execute process validation protocols and reports in accordance with regulatory requirements and industry best practices.
    • Perform risk assessments and gap analyses to identify areas for process improvement and ensure the reliability of manufacturing processes.
    • Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and other departments to support process validation activities.
    • Lead and/or participate in investigations related to process deviations, non-conformances, and CAPAs, and implement corrective and preventive actions as needed.
    • Support technology transfer activities between development and manufacturing sites, ensuring successful scale-up and transfer of processes.
    • Stay current with industry trends, regulatory requirements, and best practices related to process validation and contribute to the continuous improvement of validation processes and procedures.

    Requirements:

    • Bachelor's or master's degree in engineering, Pharmaceutical Sciences, or related field.
    • Minimum of 3 years of experience in process validation within the pharmaceutical or biotechnology industry.
    • Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH) related to process validation.
    • Experience with risk assessment methodologies (e.g., FMEA) and statistical analysis tools (e.g., Minitab) is preferred.
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